Home NDC 55873-003 OralLine Kids
Product NDC 55873-003
11-digit product format 558730003
Labeler code 55873
Product ID 55873-003_1076e667-505a-494a-865a-ee3767e3305e
Type HUMAN OTC DRUG
Nonproprietary name SODIUM FLUORIDE
Dosage form GEL, DENTIFRICE
Route ORAL
Labeler J.M. Murray Center Inc.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-03-01
Substance SODIUM FLUORIDE
Active strength .15 g/100g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 22 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 55873-003-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 55873-003-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 55873-003-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55873-003-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55873-003-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 55873-003-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 55873-003-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 55873-003-01 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 55873-003-01 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 55873-003-01 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 55873-003-01 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base OralLine Kids
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE .15 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 416783 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55873-003-01 OralLine Kids 113.4 g in 1 TUBE GEL, DENTIFRICE 113.4 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SODIUM FLUORIDE ACTIVE INGREDIENT 8ZYQ1474W7 ORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.] 1 SODIUM CATION ACTIVE MOIETY LYR4M0NH37 ORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.] 1 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 ORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.] 1 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L ORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.] 1 HYDRATED SILICA INACTIVE INGREDIENT Y6O7T4G8P9 ORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.] 1 POLYETHYLENE GLYCOL 600 INACTIVE INGREDIENT NL4J9F21N9 ORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY ORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU ORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J ORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.] 1 SODIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT 94255I6E2T ORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R ORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55873-003 ORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.] 6 Current NDC, Legacy NDC, 1 package rows 20250323_12c5bee5-e228-4f71-9bfd-c377ee2372a9.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 5 of 51 · 1,013 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55873-003-01 55873000301 113.4 g in 1 TUBE (55873-003-01) 113.4 g 2025-03-01 0000-00-00 No No Current